Regulatory Solutions—Medical Device

Submissions & Communications

The CSSi LifeSciences Regulatory Team has demonstrated tremendous success in completing a wide variety of submissions to health authorities in the U.S. and abroad. Our record speaks for itself. Our staff understands the guidances and the FDA “speak” required to successfully guide a new submission to the U.S. market.  We are experts in creating documentation that addresses FDA requirements and minimizes the need for clarifications and follow-up questions.

Our integrative process provides a 360-degree assessment to achieve positive results for the most challenging and complex submissions.

We both lead and collaborate with teams to strategize, develop, write, edit, review, and submit all required FDA technical documents and submissions. From the U.S. FDA CDRH Pre-submission Meeting Request to Investigational Device Exemptions (IDE), as well as a host of others, our team of regulatory experts will be your trusted partners through the submission process.